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临床试验/NCT07412119
NCT07412119尚未招募不适用

Research on Disease Control and Mental Health Status of Adolescent Asthma Patients

Beijing Children's Hospital0 个研究点目标入组 460 人开始时间: 2026年4月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
460
主要终点
anxiety state

研究概览

简要总结

Background: Currently in China, adolescent asthma care is characterized by both undertreatment and overtreatment. Patients in this age group may exhibit negative emotions toward disease treatment and long-term control. Insufficient disease knowledge, irregular lifestyle habits, and negative attitudes toward the disease can all reduce medication adherence, affect disease control outcomes, and thereby increase the risk of severe chronic respiratory conditions and disease burden in adulthood.

Objectives: To assess disease control status in adolescent asthma patients, evaluate the psychological well-being of patients and their family members, and understand patients' self-management skills and readiness for transition to adulthood.

Procedures: Eligible participants will complete a series of assessment questionnaires through the Youran Huxi mobile application, including questionnaires on asthma control, physical activity, psychological health, self-management behaviors, and transition readiness. The study period is 12 months; the baseline assessment involves one-time completion of written questionnaires with no interim follow-up visits. The study does not intervene in clinical diagnosis or treatment decisions.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
12 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Meet the asthma diagnostic criteria of GINA 2025
  • Age 12 to 18 years old
  • The parents and the child patient agreed and filled out the questionnaire completely.

排除标准

  • Children with other respiratory diseases such as bronchiectasis, bronchiolitis, cystic fibrosis and pneumonia
  • Combined with chronic diseases of other systems

研究组 & 干预措施

Adolescent asthma patients

Adolescents diagnosed with asthma

干预措施: Eligible participants will complete a battery of assessment questionnaires (Other)

结局指标

主要结局

anxiety state

时间窗: From the diagnosis of asthma to the end of this survey at 12month

Total scores on the Screen for Childhood Anxiety and Related Emotional Disorders (SCARED) ranging from 0 to 24 are considered within the non-clinical range, indicating minimal anxiety symptoms. SCARED total scores of 25-41 indicate mild to moderate anxiety symptoms. Scores of 42 or above suggest moderate to severe anxiety symptoms, indicating probable anxiety disorder.

depression state

时间窗: From the diagnosis of asthma to the end of this survey at 12month

A score of 16 to 19 on the Child Depression Scale (CDI) indicates mild depressive symptoms, and attention should be paid to psychological state. A score of 20 to 24 indicates moderate depressive symptoms. A score of 25 or above indicates severe depressive symptoms, suggesting the possible presence of depressive disorders.

次要结局

  • disease control level(From the 4 weeks prior to enrollment to the end of this survey at 12month)
  • Adolescent readiness for the transition period of asthma(From the diagnosis of asthma to the end of this survey at 12month)

研究者

发起方
Beijing Children's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kunling Shen

Doctor

Beijing Children's Hospital

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